Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-03-05 @ 1:04 AM
Study NCT ID:
NCT05609292
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2022-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing A Visual Thermometer in Newborns and Young Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084462', 'term': 'Hyperthermia'}, {'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-01', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the liquid crystal thermometer with measuring a temperature', 'timeFrame': 'baseline', 'description': 'determining the accuracy of the LCTD in estimating the temperature of infants 0-6 months presenting to the emergency room for treatment'}, {'measure': 'Parents/Caregivers and Healthcare provider accuracy in evaluating the infant temperature', 'timeFrame': 'baseline', 'description': 'Our secondary endpoint is determining parents/caregivers and healthcare provider accuracy in evaluating the temperature of their infant or the infant they are caring for and determining the category of the temperature.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['temperature monitoring', 'liquid crystal thermometer', 'hypothermia', 'hyperthermia', 'LCTD', 'infant temperature', 'infant hyperthermia', 'infant hypothermia', 'neonate hyperthermia', 'neonate hypothermia', 'neonate temperature'], 'conditions': ['Hyperthermia', 'Hypothermia']}, 'descriptionModule': {'briefSummary': '"Severe neonatal jaundice and acute bilirubin encephalopathy are a major cause of death and disability among newborns in LMICs. Filtered sunlight phototherapy (FSPT) was developed, tested and shown to be safe and efficacious in the treatment of jaundice, because effective electric-powered conventional phototherapy is often unavailable10,11. However, FSPT currently requires at least hourly temperature monitoring by healthcare providers (HCPs) because infants receiving FSPT are prone to both hypothermia and hyperthermia.\n\n20 years ago, a liquid crystal thermometer, ThermospotTM (Maternova, Providence, RI) was developed primarily for use in LMICs. It was designed to detect hypothermia and is most sensitive in cold infants and not as sensitive as needed for detecting hyperthermia or fever. The purpose of this pilot study is to determine the accuracy and useability of this LCTD for a wider spectrum of temperatures when used in a large group of infants in a high-income country. If the device performs well in this study, we plan to study it in a low- and middle-income country in Africa."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '0 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants between the age of 0-6months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants 0-6 months (\\<7 months) presenting to Masonic Emergency Room or inpatient ward, their parent or caregiver who provide verbal consent in English or through a medical interpreter.\n\nExclusion Criteria:\n\n* Any infant undergoing active resuscitation\n* any infant for whom physician deems study enrollment would interfere with their care\n* any infant whose parents or caregiver decline enrollment\n* any nurse or other healthcare provider who declines participation\n* Parents who do not understand English, and do not have a medical interpreter at the bedside.'}, 'identificationModule': {'nctId': 'NCT05609292', 'briefTitle': 'Testing A Visual Thermometer in Newborns and Young Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Testing A Visual Thermometer in Newborns and Young Infants', 'orgStudyIdInfo': {'id': 'new'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Infants will get their temperature measured with the liquid crystal thermometer. We are not providing any interventions as they will be in the care of a healthcare team.', 'interventionNames': ['Device: observational']}], 'interventions': [{'name': 'observational', 'type': 'DEVICE', 'description': 'Infants will get their temperature measured with the liquid crystal thermometer. We are not providing any interventions as they will be in the care of a healthcare team.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Tina Slusher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}